For Patients

Mirena (levonorgestrel-releasing intrauterine device) is a form of birth control that is indicated for intrauterine contraception for up to 5 years and for the treatment of heavy menstrual bleeding in women. Mirena is a hormone-releasing system placed in your uterus to prevent pregnancy for up to 5 years and should be inserted by a trained healthcare provider. The most common side effects of Mirena are amenorrhea, intermenstrual bleeding and spotting, abdominal/pelvic pain, ovarian cysts, headache/migraine, acne, and depressed/altered mood.

Drug interactions and warnings include potential interactions with insulin, warfarin (Coumadin) and steroids. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Many studies have found no harmful effects on fetal development associated with long-term use of contraceptives including Mirena. Small amounts of progestins pass into the breast milk of nursing mothers, resulting in detectable steroid levels in infant serum.

Our Mirena Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Get emergency medical help if you have severe pain in your lower stomach or side. This could be a sign of a tubal pregnancy (a pregnancy that implants in the fallopian tube instead of the uterus). A tubal pregnancy is a medical emergency.

The levonorgestrel intrauterine device may become embedded into the wall of the uterus, or may perforate (form a hole) in the uterus. If this occurs, the device may no longer prevent pregnancy, or it may move outside the uterus and cause scarring, infection, or damage to other organs. If the device embeds in or perforates the uterine wall, your doctor may need to surgically remove the device.

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical studies of
a drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in practice.

The data provided reflect the experience with the use of
Mirena in the adequate and well-controlled studies for contraception (n=2,339)
and heavy menstrual bleeding (n=80). For the contraception indication, Mirena
was compared to a copper IUD (n=1,855), to another formulation of LNG IUS
(n=390) and to a combined oral contraceptive (n=94) in women 18 to 35 years
old. The data cover more than 92,000 woman-months of exposure. For the
treatment of heavy menstrual bleeding indication (n=80), the subjects included
women aged 26 to 50 with confirmed heavy bleeding and exposed for a median of
183 treatment days of Mirena (range 7 to 295 days). The frequencies of reported
adverse drug reactions represent crude incidences.

The adverse reactions seen across the two indications
overlapped, and are reported using the frequencies from the contraception
studies.

Postmarketing Experience

The following adverse reactions have been identified
during post approval use of Mirena. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always possible to
reliably estimate their frequency or establish a causal relationship to drug
exposure.